A Study on the Effects of Dextrose Solutions on the Course of Labor

This study has been completed.
Sponsor:
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00569439
First received: December 6, 2007
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

The purpose is to determine in term nulliparas with singletons that present in active labor (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to normal saline improves or expedites the course of labor. The researchers' hypothesis is that the addition of a carbohydrate substrate will shorten the length of labor and facilitate a vaginal delivery.


Condition Intervention Phase
Labor
Drug: D5NS
Drug: D10NS
Drug: NS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Normal Saline With and Without Dextrose on the Course of Labor in Nulliparas

Resource links provided by NLM:


Further study details as provided by MemorialCare:

Primary Outcome Measures:
  • Carbohydrate solutions can decrease the total duration of labor by 20% (from 560 minutes to 450 minutes) [ Time Frame: Prospective ]

Secondary Outcome Measures:
  • Carbohydrate solutions can decrease the incidence of prolonged labor (> 12 hours [ Time Frame: Prospective ]
  • Carbohydrate solutions can decrease the incidence of chorioamnionitis during labor [ Time Frame: Prospective ]
  • Carbohydrate solutions can decrease the need for oxytocin (a contraction stimulant) augmentation of labor [ Time Frame: Prospective ]
  • Carbohydrate solutions can decrease the frequency of cesarean sections for prolonged labor [ Time Frame: Prospective ]

Enrollment: 301
Study Start Date: November 2000
Study Completion Date: June 2007
Arms Assigned Interventions
Experimental: D5
5% Dextrose Solution in Normal Saline
Drug: D5NS
5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr
Experimental: D10 Drug: D10NS
10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr
Placebo Comparator: NS Drug: NS
Normal Saline solution at 125 cc/hr

Detailed Description:

Factors that affect the course of labor have been studied extensively. Surprisingly, there is little data on the effect that different types and rates of intravenous (IV) fluids have during labor. Exercise physiologists have shown that increased fluid intake and carbohydrate replacement improve skeletal muscle performance in prolonged exercise. In a 1992 randomized, controlled study comparing IV fluid rates, Garite et al. showed a lower frequency of prolonged labor, and possibly a decreased need for oxytocin, with higher IV fluid rates in labor. Inadequate hydration may contribute to dysfunctional labor and possibly an increased rate of cesarean section.

We propose that inadequate carbohydrate replacement in labor may also contribute to prolongation of labor and increased need for operative delivery. Glucose is the main energy supply for the pregnant uterus. Physiological requirements for glucose during labor are approximately 10 grams per hour. Adequate supplies of glucose are needed to maintain exercise tolerance and muscle efficiency, which are important factors in the progress of labor. Dysfunctional labor or dystocia, which is the leading indication for primary cesarean delivery, is caused by uterine forces insufficiently strong or inappropriately coordinated to efface and dilate the cervix. Dystocia can also be a result of inadequate voluntary muscle effort in the second stage of labor. It contributes to increased risk for chorioamnionitis, which is a leading cause of maternal and fetal morbidity and mortality. Supplying carbohydrate fuel for working uterine and skeletal muscle may improve progress in labor and, therefore, diminish risk for chorioamnionitis and need for cesarean delivery.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Primiparous
  • Singleton gestation
  • Vertex presentation
  • Spontaneous active labor with or without pitocin augmentation
  • Gestational age > 36 weeks
  • Cervical dilation 3 to 5 cm with or without ruptured membranes

Exclusion Criteria:

  • Multiparous
  • Pregestational or gestational diabetes mellitus
  • Preeclampsia at admission
  • Previous cesarean section
  • Non-vertex presentation
  • Multiple gestation
  • Chorioamnionitis at admission
  • Intrauterine growth restriction (< 10th percentile)
  • Patients admitted for induction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569439

Sponsors and Collaborators
MemorialCare
Investigators
Principal Investigator: Kenneth Chan, M.D. Memorial Care
Principal Investigator: Sherri Jenkins, M.D. University of Alabama at Birmingham
Principal Investigator: Thomas J. Garite, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Kenneth Chan, Memorial Care
ClinicalTrials.gov Identifier: NCT00569439     History of Changes
Other Study ID Numbers: 035-00
Study First Received: December 6, 2007
Last Updated: December 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare:
Labor
Carbohydrate
Dystocia

ClinicalTrials.gov processed this record on July 24, 2014